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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02348489




Registration number
NCT02348489
Ethics application status
Date submitted
22/01/2015
Date registered
28/01/2015
Date last updated
27/08/2024

Titles & IDs
Public title
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
Scientific title
A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy
Secondary ID [1] 0 0
SGI-110-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SGI-110 (guadecitabine)
Treatment: Drugs - Treatment Choice

Experimental: SGI-110 (guadecitabine) - Guadecitabine 60 mg/m\^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.

Active comparator: Treatment Choice - One of the following treatment regimens: 20 mg cytarabine administered subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.


Treatment: Drugs: SGI-110 (guadecitabine)
Investigational medicinal product

Treatment: Drugs: Treatment Choice
Choice of one: cytarabine, decitabine, or azacitidine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With a Complete Response (CR)
Timepoint [1] 0 0
Up to 38 months (median follow-up of 25.5 months)
Primary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
At 676 death events (up to 38 months)
Secondary outcome [1] 0 0
Number of Participants With Composite CR (CRc)
Timepoint [1] 0 0
Up to 38 months (median follow-up of 25.5 months)
Secondary outcome [2] 0 0
Number of Days Alive and Out of the Hospital
Timepoint [2] 0 0
Month 6
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to 38 months (median follow-up of 25.5 months)
Secondary outcome [4] 0 0
Number of Red Blood Cell or Platelet Transfusions
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Timepoint [5] 0 0
Baseline to Month 6
Secondary outcome [6] 0 0
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Timepoint [6] 0 0
Baseline to Month 6
Secondary outcome [7] 0 0
Duration of CR
Timepoint [7] 0 0
Up to 38 months (median follow-up of 25.5 months)

Eligibility
Key inclusion criteria
Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification.

Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed.

Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:

1. =75 years of age OR
2. <75 years of age with at least 1 of the following:

i. Poor performance status (ECOG) score of 2-3.

ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:

1. Left ventricular ejection fraction (LVEF) =50%.
2. Lung diffusing capacity for carbon monoxide (DLCO) =65% of expected.
3. Forced expiratory volume in 1 second (FEV1) =65% of expected.
4. Chronic stable angina or congestive heart failure controlled with medication.

iii. Liver transaminases >3 × upper limit of normal (ULN).

iv. Other contraindication(s) to anthracycline therapy (must be documented).

v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization.

Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas =30 mL/min.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidate for intensive remission induction chemotherapy at the time of enrollment.

Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators.

Known extramedullary central nervous system (CNS) AML.

Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

Prior treatment with decitabine or azacitidine.

Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.

Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.

Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.

Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute (LPM) oxygen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/06/2019
Sample size
Target
Accrual to date
Final
815
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment outside Australia
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United States of America
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Arizona
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California
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Illinois
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Kansas
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Minnesota
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Wisconsin
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Austria
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Styria
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Austria
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Vienna
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Belgium
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Hainaut
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Belgium
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Plovdiv
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Varna
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Czechia
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Jihormoravsky KRAJ
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Czechia
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Praha
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Czechia
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Praha 10
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Aarhus
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Copenhagen
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Odense
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Southern Finland
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Finland
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Helsinki
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France
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Alsace
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France
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Aquitaine
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Midi-pyrenees
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PAYS DE LA Loire
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France
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Provence Alpes COTE D'azur
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France
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Rhone-alpes
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Germany
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Baden-wuerttemberg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-westfalen
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Germany
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Schleswig-holstein
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Hungary
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Bacs-kiskun
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Hungary
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Budapest
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Debrecen
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Kaposvár
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Italy
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Pesaro E Urbino
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Potenza
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Torino
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Alessandria
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Bologna
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Busto Arsizio
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Italy
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Catania
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Genova
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Milano
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Modena
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Napoli
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Roma
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Udine
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Kanto
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Kyushu
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Gyeonggi-do
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Opolskie
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Slaskie
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Mures
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Iasi
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Russian Federation
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Ekaterinburg
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Russian Federation
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Ryazan
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Russian Federation
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Saratov
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Serbia
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Belgrade
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Serbia
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Novi Sad
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Spain
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Asturias
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Barcelona
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Caceres
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Granada
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Madrid
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Skane
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Sweden
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Stockholm
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Taiwan
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Taoyuan
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Taichung
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Taipei
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United Kingdom
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England
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United Kingdom
State/province [104] 0 0
Kent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astex Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT02348489
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02348489